Unicompartmental customized arthroplasty cutting jigs

ABSTRACT

Disclosed herein are unicompartmental femoral and tibial arthroplasty jigs for respectively assisting in the performance of unicompartmental femoral and tibial arthroplasty procedures on femoral and tibial arthroplasty target regions. The jigs each include a mating surface. The mating surface of the femoral jig is configured to matingly receive and contact a generally planar area of an anterior side of a femoral shaft generally proximal of the patellar facet border and generally distal an articularis genu. The mating surface of the tibial jig is configured to matingly receive and contact a generally planar area of an anterior side of a tibial shaft distal of the tibial plateau edge and generally proximal of the tibial tuberosity.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. application Ser. No.12/636,939, filed Dec. 14, 2009, which application claims priority under35 U.S.C. §119 to U.S. provisional patent application 61/122,842, whichwas filed Dec. 16, 2008, entitled “Uni-Compartmental CustomizedArthroplasty Cutting Jigs And Methods Of Making The Same.” All of theabove-identified applications are hereby incorporated by reference intheir entirety into the present application.

FIELD OF THE INVENTION

The present invention relates to arthroplasty cutting jigs and systemsand methods for manufacturing such jigs. More specifically, the presentinvention relates to uni-compartmental customized arthroplasty cuttingjigs and automated systems and methods of manufacturing such jigs.

BACKGROUND

Over time and through repeated use, bones and joints can become damagedor worn. For example, repetitive strain on bones and joints (e.g.,through athletic activity), traumatic events, and certain diseases(e.g., arthritis) can cause cartilage in joint areas, which normallyprovides a cushioning effect, to wear down. When the cartilage wearsdown, fluid can accumulate in the joint areas, resulting in pain,stiffness, and decreased mobility.

Arthroplasty procedures can be used to repair damaged joints. During atypical arthroplasty procedure, an arthritic or otherwise dysfunctionaljoint can be remodeled or realigned, or an implant can be implanted intothe damaged region. Arthroplasty procedures may take place in any of anumber of different regions of the body, such as a knee, a hip, ashoulder, or an elbow.

One type of arthroplasty procedure is a total knee arthroplasty (“TKA”),in which a damaged knee joint is replaced with prosthetic implants. Theknee joint may have been damaged by, for example, arthritis (e.g.,severe osteoarthritis or degenerative arthritis), trauma, or a raredestructive joint disease. Typically, a candidate for a TKA hassignificant wear or damage in two or more “compartments” of the knee.The knee is generally divided into three “compartments”: medial (theinside part of the knee), lateral (the outside part of the knee) and thepatellofemoral (the joint between the kneecap and the thighbone). Duringa TKA procedure, a damaged portion in the distal region of the femur maybe removed and replaced with a metal shell, and a damaged portion in theproximal region of the tibia may be removed and replaced with achanneled piece of plastic having a metal stem. In some TKA procedures,a plastic button may also be added under the surface of the patella,depending on the condition of the patella.

Another type of procedure is a unicompartmental (knee) arthroplasty orpartial knee replacement (“UKA”) in which only a portion (or a singlecompartment) of the knee is replaced with prosthetic implants.Typically, a candidate for a UKA has significant wear or damage confinedto primarily one compartment of the knee. A UKA may be a less invasiveapproach than a TKR and may have a quicker recovery time. A UKA may beutilized to prevent the spread of disease, such as in the early stagesof osteoarthritis, where the disease has only affected a portion of theknee and it is desirable to prevent the disease from spreading to otherportions of the knee.

Implants that are implanted into a damaged region may provide supportand structure to the damaged region, and may help to restore the damagedregion, thereby enhancing its functionality. Prior to implantation of animplant in a damaged region, the damaged region may be prepared toreceive the implant. For example, in a knee arthroplasty procedure, oneor more of the bones in the knee area, such as the femur and/or thetibia, may be treated (e.g., cut, drilled, reamed, and/or resurfaced) toprovide one or more surfaces that can align with the implant and therebyaccommodate the implant.

Accuracy in implant alignment is an important factor to the success of aTKA or a UKA procedure. A one- to two-millimeter translationalmisalignment, or a one- to two-degree rotational misalignment, mayresult in imbalanced ligaments, and may thereby significantly affect theoutcome of the procedure. For example, implant misalignment may resultin intolerable post-surgery pain, and also may prevent the patient fromhaving full leg extension and stable leg flexion.

To achieve accurate implant alignment, prior to treating (e.g., cutting,drilling, reaming, and/or resurfacing) any regions of a bone, it isimportant to correctly determine the location at which the treatmentwill take place and how the treatment will be oriented. In some methods,an arthroplasty jig may be used to accurately position and orient afinishing instrument, such as a cutting, drilling, reaming, orresurfacing instrument on the regions of the bone. The arthroplasty jigmay, for example, include one or more apertures and/or slots that areconfigured to accept such an instrument. However, under some methods, itmay be difficult to determine the proper orientation of an arthroplastyjig, and more specifically, of a unicompartmental arthroplasty jig.

A system and method has been developed for producing customizedarthroplasty jigs configured to allow a surgeon to accurately andquickly perform an arthroplasty procedure that restores thepre-deterioration alignment of the joint, thereby improving the successrate of such procedures. Specifically, the customized arthroplasty jigsare indexed such that they matingly receive the regions of the bone tobe subjected to a treatment (e.g., cutting, drilling, reaming, and/orresurfacing). The customized arthroplasty jigs are also indexed toprovide the proper location and orientation of the treatment relative tothe regions of the bone. The indexing aspect of the customizedarthroplasty jigs allows the treatment of the bone regions to be donequickly and with a high degree of accuracy that will allow the implantsto restore the patient's joint to a generally pre-deteriorated state.However, the system and method for generating the customized jigs oftenrelies on a human to “eyeball” bone models on a computer screen todetermine configurations needed for the generation of the customizedjigs. This “eyeballing” or manual manipulation of the bone models on thecomputer screen is inefficient and unnecessarily raises the time,manpower and costs associated with producing the customized arthroplastyjigs. Furthermore, a less manual approach may improve the accuracy ofthe resulting jigs.

There is a need in the art for customized uni-compartmental arthroplastyjigs and methods of planning and generating such a jig. There is a needin the art for a system and method for reducing the labor associatedwith generating customized arthroplasty jigs. There is also a need inthe art for a system and method for increasing the accuracy ofcustomized arthroplasty jigs.

SUMMARY

Disclosed herein is an unicompartmental femoral arthroplasty jig forassisting in the performance of an unicompartmental femoral arthroplastyprocedure on a femoral arthroplasty target region. In one embodiment,the unicompartmental femoral arthroplasty jig includes a first side, asecond side and a mating surface. The second side is generally oppositethe first side. The mating surface is in the first side and configuredto matingly receive and contact certain surfaces of the femoralarthroplasty target region. The certain surfaces are limited to andinclude a medial articular condyle surface, an articular trochleargroove surface, and a generally planar area of an anterior side of afemoral shaft. The first side is configured to be oriented towards thefemoral arthroplasty target region surface when the mating surfacematingly receives and contacts the certain surfaces.

In one version of the embodiment, the unicompartmental femoralarthroplasty jig further includes a cutting guide surface positioned andoriented relative to the mating surface to result in a cut in thefemoral arthroplasty target region with a desired position andorientation. In some cases, the desired position and orientation mayallow a prosthetic femoral implant to restore a patient's knee joint toa natural alignment and, in other cases, the restoration may be to azero degree mechanical axis alignment.

In one version of the embodiment of the unicompartmental femoralarthroplasty jig, the certain surfaces associated with the medialarticular condyle surface are generally limited to an anterior anddistal regions of the medial articular condyle surface.

In one version of the embodiment of the unicompartmental femoralarthroplasty jig, the certain surfaces associated with the articulartrochlear groove surface are generally limited to an anterior and distalregions of a medial articular trochlear groove surface.

In one version of the embodiment of the unicompartmental femoralarthroplasty jig, the certain surfaces associated with the articulartrochlear groove surface are generally limited to regions of a lateralarticular trochlear groove surface and a medial articular trochleargroove surface.

In one version of the embodiment of the unicompartmental femoralarthroplasty jig, the certain surfaces associated with the articulartrochlear groove surface are generally limited to anterior and distalregions of a lateral articular trochlear groove surface and anterior anddistal regions of a medial articular trochlear groove surface.

In one version of the embodiment of the unicompartmental femoralarthroplasty jig, the certain surfaces associated with the generallyplanar area of the anterior side of the femoral shaft are generallylimited to being generally distal of the articulars genu and generallyproximal of the anterior patellar facet boarder.

In one version of the embodiment of the unicompartmental femoralarthroplasty jig, the certain surfaces associated with the generallyplanar area of the anterior side of the femoral shaft are generallylimited to: being generally distal of the articulars genu and generallyproximal of the anterior patellar facet boarder; and at least onecontact point with the anterior patellar facet boarder.

Also disclosed herein is an unicompartmental tibial arthroplasty jig forassisting in the performance of an unicompartmental tibial arthroplastyprocedure on a tibial arthroplasty target region. In one embodiment, theunicompartmental tibial arthroplasty jig includes a first side, a secondside and a mating surface. The second side is generally opposite thefirst side. The mating surface is in the first side and configured tomatingly receive and contact certain surfaces of the tibial arthroplastytarget region. The certain surfaces are limited to and include a medialarticular plateau surface, an intercondyloid eminence surface, and agenerally planar area of an anterior side of a tibial shaft. The firstside is configured to be oriented towards the tibial arthroplasty targetregion surface when the mating surface matingly receives and contactsthe certain surfaces.

In one version of the embodiment, the unicompartmental tibialarthroplasty jig further includes a cutting guide surface positioned andoriented relative to the mating surface to result in a cut in the tibialarthroplasty target region with a desired position and orientation. Insome cases, the desired position and orientation may allow a prosthetictibial implant to restore a patient's knee joint to a natural alignmentand, in other cases, the restoration may be to a zero degree mechanicalaxis alignment.

In one version of the embodiment of the unicompartmental tibialarthroplasty jig, the certain surfaces associated with the generallyplanar area of the anterior side of the tibial shaft are generallylimited to being generally distal of the tibial plateau edge andgenerally proximal of the tibial tuberosity.

In one version of the embodiment of the unicompartmental tibialarthroplasty jig, the certain surfaces associated with theintercondyloid eminence are generally limited to a medial upslope of theintercondyloid eminence.

In one version of the embodiment of the unicompartmental tibialarthroplasty jig, the certain surfaces associated with theintercondyloid eminence are generally limited to a medial upslope of theintercondyloid eminence and a region extending from anterior theintercondyloid eminence to towards a tuberosity over an edge transitionfrom a tibial plateau region. In some such cases, at least one of thecertain surfaces associated with the intercondyloid eminence merges withat least one of the certain surfaces associated with the generallyplanar area of the anterior side of the tibial shaft.

Further disclosed herein is an unicompartmental femoral arthroplasty jigfor assisting in the performance of an unicompartmental femoralarthroplasty procedure on a femoral arthroplasty target region. In oneembodiment, the unicompartmental femoral arthroplasty jig includes afirst side, a second side and a mating surface. The second side isgenerally opposite the first side. The mating surface is in the firstside and configured to matingly receive and contact a generally planararea of an anterior side of a femoral shaft generally proximal of thepatellar facet boarder and generally distal an articularis genu. Thefirst side is configured to be oriented towards the femoral arthroplastytarget region surface when the mating surface matingly receives andcontacts the planar area.

Yet further disclosed herein is an unicompartmental tibial arthroplastyjig for assisting in the performance of an unicompartmental tibialarthroplasty procedure on a tibial arthroplasty target region. In oneembodiment, the unicompartmental tibial arthroplasty jig includes afirst side, a second side and a mating surface. The second side isgenerally opposite the first side. The mating surface is in the firstside and configured to matingly receive and contact a generally planararea of an anterior side of a tibial shaft distal of the tibial plateauedge and generally proximal of the tibial tuberosity. The first side isconfigured to be oriented towards the tibial arthroplasty target regionsurface when the mating surface matingly receives and contacts theplanar area.

In one version of the embodiment of the unicompartmental tibialarthroplasty jig, the generally planar area includes a portion thatextends distally from generally the tibial plateau edge to a pointgenerally even with the beginning of a distal half to distal third ofthe tibial tuberosity. In some such cases, the portion extendsmedial-lateral from a medial edge of a medial tibia condyle to a pointgenerally even with a medial edge of the tibial tuberosity.

In one version of the embodiment of the unicompartmental tibialarthroplasty jig, the generally planar area includes a portion thatextends distally from generally the tibial plateau edge to a point neara proximal boundary of the tibial tuberosity. In some such cases, theportion extends medial-lateral generally between a lateral edge and amedial edge of the tibial tuberosity.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various aspects, all withoutdeparting from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic diagram of a system for employing the automatedjig production method disclosed herein.

FIGS. 1B-1E are flow chart diagrams outlining the jig production methoddisclosed herein.

FIG. 1F is a distal axial view of the three dimensional (“3D”) restoredfemoral bone model and the 3D femoral unicompartmental implant modeladjacent to each other.

FIG. 1G is a posterior coronal view of the three dimensional (“3D”)restored femoral bone model and the 3D femoral unicompartmental implantmodel adjacent to each other.

FIG. 1H illustrates adjacent posterior coronal and distal axial views ofthe 3D restored femoral bone model.

FIG. 1I illustrates the same adjacent views of the 3D restored femoralbone model as depicted in FIG. 1H, except the 3D femoralunicompartmental implant model is shape matched to the 3D restoredfemoral bone model.

FIG. 1J is an isometric view of the 3D femoral and tibialunicompartmental implant models interfaced with each other.

FIG. 1K illustrates adjacent posterior coronal and anterior coronalviews of the 3D restored femoral and tibial bone models interfaced witheach other.

FIG. 1L illustrates a proximal axial view of the 3D restored tibial bonemodel with the 3D tibial unicompartmental implant model shape matchedthereto.

FIG. 1M is a coronal-sagital view of the 3D restored femoral and tibialbone models interfaced with each other.

FIGS. 2A-2B are isometric views of a uni-compartmental femurarthroplasty jig that may be produced by the methods disclosed herein ina customized state, wherein the jig is shown either on (FIG. 2A) or off(FIG. 2B) the distal femur.

FIG. 2C depicts a top view of the uni-compartmental femur arthroplastyjig, wherein the femur is not shown, the jig being in a customizedstate.

FIG. 2D depicts a bottom view of the uni-compartmental femurarthroplasty jig of FIG. 2C.

FIG. 2E depicts a top-side isometric view of the uni-compartmental femurarthroplasty jig of FIG. 2C, wherein the jig is in a non-customizedstate or, in other words, in the form of a jig blank from which the jigin manufactured.

FIG. 3A illustrates how the uni-compartmental femur arthroplasty jig ofFIG. 2A may be sized based on the medial condyle.

FIG. 3B illustrates the area in the trochlear groove and the anteriorcortex that may be covered by the jig of FIG. 2A.

FIG. 3C illustrates how the size of the anterior flange of the jig ofFIG. 2A may be determined.

FIGS. 4A and 4B are, respectively, coronal and distal views of thefemoral condyles and displaying one embodiment of the mating surfacesfor the uni-compartmental arthroplasty femur jig about the distalfemoral condyle.

FIGS. 5A and 5B are, respectively, coronal and distal views of femoralcondyles and displaying an embodiment having a reduced number of matingsurfaces that still provides adequate stability of the uni-compartmentalarthroplasty femur jig about the distal femoral condyle.

FIG. 6 is an isometric view of the uni-compartmental arthroplasty femurjig with mating surfaces corresponding to those of the distal femoralcondyle depicted in FIGS. 4A and 4B.

FIG. 7 illustrates mating and hooking of the anterior flange of theuni-compartmental arthroplasty femur jig about the edge of theanterior-proximal trochlear groove.

FIG. 8 illustrates one method of mating to the trochlear groove.

FIG. 9 illustrates full mating of the trochlear groove.

FIG. 10 illustrates a single MRI slice in the sagittal plane with threeconsecutive segmentation outlines where the corresponding outline hooksthe edge of the anterior-proximal trochlear groove.

FIG. 11A is an isometric view of a uni-compartmental tibial arthroplastyjig that may be produced by the methods disclosed herein in a customizedstate, wherein the jig is shown on the proximal tibia.

FIG. 11B is the tibial arthroplasty jig of FIG. 11B, except the jig isshown off the proximal tibia.

FIG. 11C depicts a top view of the uni-compartmental tibial arthroplastyjig, wherein the tibia is not shown.

FIG. 11D depicts a bottom view of the uni-compartmental tibialarthroplasty jig of FIG. 11C.

FIG. 11E depicts a top view of the uni-compartmental tibial arthroplastyjig of FIG. 11C, except the jig is in a non-customized state.

FIG. 12A illustrates the length of the tibial plateau that oneembodiment of the tibial jig may cover.

FIG. 12B illustrates the height of one embodiment of the tibial jig.

FIGS. 13A and 13B are, respectively, an anterior coronal view and aproximal axial view of one embodiment of the mating surfaces for thetibial arthroplasty jig on the proximal tibia.

FIGS. 14A-14B are, respectively, an anterior coronal view and a proximalaxial view of a second embodiment of the mating surfaces for the tibialarthroplasty jig on the proximal tibia.

FIG. 15 illustrates the uni-compartmental tibial arthroplasty jig withmating surfaces corresponding to those of the proximal tibia depicted inFIGS. 13A-13B.

FIG. 16 is a single MRI slice in the sagittal plane at the medialupslope of the intercondyloid eminence.

FIG. 17A illustrates one method of the uni-compartmental tibialarthroplasty jig mating with the medial upslope of the intercondyloideminence.

FIG. 17B is an enlarged view of FIG. 17A.

FIG. 18A illustrates another method of the uni-compartmental tibialarthroplasty jig mating with the medial upslope of the intercondyloideminence.

FIG. 18B is an enlarged view of FIG. 18A.

FIG. 19 is a flow chart outlining production to use of the arthroplastyjigs of FIGS. 2A and 11A.

DETAILED DESCRIPTION

Disclosed herein are customized uni-compartmental arthroplasty jigs 2and systems 4 for, and methods of, producing such jigs 2. The jigs 2 arecustomized to fit specific bone surfaces of specific patients. Dependingon the embodiment and to a greater or lesser extent, the jigs 2 areautomatically planned and generated and may be similar to thosedisclosed in these three U.S. patent applications: U.S. patentapplication Ser. No. 11/656,323 to Park et al., titled “ArthroplastyDevices and Related Methods” and filed Jan. 19, 2007; U.S. patentapplication Ser. No. 10/146,862 to Park et al., titled “Improved TotalJoint Arthroplasty System” and filed May 15, 2002; and U.S. patent Ser.No. 11/642,385 to Park et al., titled “Arthroplasty Devices and RelatedMethods” and filed Dec. 19, 2006. The disclosures of these three U.S.patent applications are incorporated by reference in their entiretiesinto this Detailed Description.

A. Overview of System and Method for Manufacturing CustomizedArthroplasty Cutting Jigs

For an overview discussion of the systems 4 for, and methods of,producing the customized uni-compartmental arthroplasty jigs 2,reference is made to FIGS. 1A-1L. FIG. 1A is a schematic diagram of asystem 4 for employing the automated jig production method disclosedherein. FIGS. 1B-1E are flow chart diagrams outlining the jig productionmethod disclosed herein. FIGS. 1F-1L show the 3D computer models ofseveral steps outlined in the flow chart diagrams of FIGS. 1B-1E. Thefollowing overview discussion can be broken down into three sections.

The first section, which is discussed with respect to FIG. 1A and[blocks 100-125] of FIGS. 1B-1E, pertains to an example method ofdetermining, in a three-dimensional (“3D”) computer model environment,saw cut and drill hole locations 30, 32 relative to 3D computer modelsthat are termed restored bone models 28. The resulting “saw cut anddrill hole data” 44 is referenced to the restored bone models 28 toprovide saw cuts and drill holes that will allow arthroplasty implantsto restore the patient's joint to its pre-degenerated or naturalalignment state. Depending on the damage to the actual cartilage andbone of the patient's joint that is the target of the arthroplasty, thebone model 22 may or may not be “restored” to a greater or lesser extentinto a restored bone model 28.

The second section, which is discussed with respect to FIG. 1A and[blocks 100-105 and 130-145] of FIGS. 1B-1E, pertains to an examplemethod of importing into 3D computer generated uni-compartmental jigmodels 38 3D computer generated surface models 40 of arthroplasty targetareas 42 of 3D computer generated arthritic models 36 of the patient'sjoint bones. The resulting “jig data” 46 is used to produce a jigcustomized to matingly receive the arthroplasty target areas of therespective bones of the patient's joint.

The third section, which is discussed with respect to FIG. 1A and[blocks 150-165] of FIG. 1E, pertains to a method of combining orintegrating the “saw cut and drill hole data” 44 with the “jig data” 46to result in “integrated jig data” 48. The “integrated jig data” 48 isprovided to the CNC machine 10 or other rapid production machine (e.g.,a stereolithography apparatus (“SLA”) machine) for the production ofcustomized arthroplasty jigs 2 from jig blanks 50 provided to the CNCmachine 10. The resulting customized arthroplasty jigs 2 include saw cutslots and drill holes positioned in the jigs 2 such that when the jigs 2matingly receive the arthroplasty target areas of the patient's bones,the cut slots and drill holes facilitate preparing the arthroplastytarget areas in a manner that allows the arthroplasty joint implants togenerally restore the patient's joint line to its pre-degenerated stateor natural alignment state.

As shown in FIG. 1A, the system 4 includes a computer 6 having a CPU 8,a monitor or screen 9 and an operator interface controls 11. Thecomputer 6 is linked to a medical imaging system 8, such as a CT or MRImachine 8, and a computer controlled machining system 10, such as a CNCmilling machine 10.

As indicated in FIG. 1A, a patient 12 has a joint 14 (e.g., a knee,elbow, ankle, wrist, hip, shoulder, skull/vertebrae orvertebrae/vertebrae interface, etc.) to be replaced. The patient 12 hasthe joint 14 scanned in the imaging machine 8. The imaging machine 8makes a plurality of scans of the joint 14, wherein each scan pertainsto a thin slice of the joint 14.

As can be understood from FIG. 1B, the plurality of scans is used togenerate a plurality of two-dimensional (“2D”) images 16 of the joint 14[block 100]. Where, for example, the joint 14 is a knee 14, the 2Dimages will be of the femur 18 and tibia 20. The imaging may beperformed via CT or MRI. In one embodiment employing MRI, the imagingprocess may be as disclosed in U.S. patent application Ser. No.11/946,002 to Park, which is entitled “Generating MRI Images Usable ForThe Creation Of 3D Bone Models Employed To Make Customized ArthroplastyJigs,” was filed Nov. 27, 2007 and is incorporated by reference in itsentirety into this Detailed Description.

As can be understood from FIG. 1A, the 2D images are sent to thecomputer 6 for creating computer generated 3D models. As indicated inFIG. 1B, in one embodiment, point P is identified in the 2D images 16[block 105]. In one embodiment, as indicated in [block 105] of FIG. 1A,point P may be at the approximate medial-lateral and anterior-posteriorcenter of the patient's joint 14. In other embodiments, point P may beat any other location in the 2D images 16, including anywhere on, nearor away from the bones 18, 20 or the joint 14 formed by the bones 18,20.

As described later in this overview, point P may be used to locate thecomputer generated 3D models 22, 28, 36 created from the 2D images 16and to integrate information generated via the 3D models. Depending onthe embodiment, point P, which serves as a position and/or orientationreference, may be a single point, two points, three points, a point plusa plane, a vector, etc., so long as the reference P can be used toposition and/or orient the 3D models 22, 28, 36 generated via the 2Dimages 16.

As shown in FIG. 1C-1, the 2D images 16 are employed to create computergenerated 3D bone-only (i.e., “bone models”) 22 of the bones 18, 20forming the patient's joint 14 [block 110]. The bone models 22 arelocated such that point P is at coordinates (X_(0-j), Y_(0-j), Z_(0-j))relative to an origin (X₀, Y₀, Z₀) of an X—Y—Z axis [block 110]. Thebone models 22 depict the bones 18, 20 in the present deterioratedcondition with their respective degenerated joint surfaces 24, 26, whichmay be a result of osteoarthritis, injury, a combination thereof, etc.The degeneration may be minimal such that it is cartilage damage onlyand no bone damage. Alternatively, the degeneration may be moresignificant such that the damage is both to the cartilage and the bone.

In one embodiment, the bone surface contour lines of the bones 18, 20depicted in the image slices 16 may be auto segmented via an imagesegmentation process as disclosed in U.S. Patent Application 61/126,102,which was filed Apr. 30, 2008, is entitled System and Method for ImageSegmentation in Generating Computer Models of a Joint to UndergoArthroplasty, and is hereby incorporated by reference into the presentapplication in its entirety.

Computer programs for creating the 3D computer generated bone models 22from the 2D images 16 include: Analyze from AnalyzeDirect, Inc.,Overland Park, Kans.; Insight Toolkit, an open-source software availablefrom the National Library of Medicine Insight Segmentation andRegistration Toolkit (“ITK”), www.itk.org; 3D Slicer, an open-sourcesoftware available from www.slicer.org; Mimics from Materialise, AnnArbor, Mich.; and Paraview available at www.paraview.org.

As indicated in FIG. 1C-1, the 3D computer generated bone models 22 areutilized to create 3D computer generated “restored bone models” or“planning bone models” 28 wherein the degenerated surfaces 24, 26 aremodified or restored to approximately their respective conditions priorto degeneration [block 115]. Thus, the bones 18, 20 of the restored bonemodels 28 are reflected in approximately their condition prior todegeneration. The restored bone models 28 are located such that point Pis at coordinates (X_(0-j), Y_(0-j), Z_(0-j)) relative to the origin(X₀, Y₀, Z₀). Thus, the restored bone models 28 share the sameorientation and positioning relative to the origin (X₀, Y₀, Z₀) as thebone models 22. If damage is minimal to the bone (e.g., the damage is tothe cartilage, only), the bone model 22 may not need much, if any,restoration, and the bone model 22 may be used as the restored bonemodel 28 for purposes of the process described herein.

In one embodiment, the restored bone models 28 are manually created fromthe bone models 22 by a person sitting in front of a computer 6 andvisually observing the bone models 22 and their degenerated surfaces 24,26 as 3D computer models on a computer screen 9. The person visuallyobserves the degenerated surfaces 24, 26 to determine how and to whatextent the degenerated surfaces 24, 26 surfaces on the 3D computer bonemodels 22 need to be modified to restore them to their pre-degeneratedcondition. By interacting with the computer controls 11, the person thenmanually manipulates the 3D degenerated surfaces 24, 26 via the 3Dmodeling computer program to restore the surfaces 24, 26 to a state theperson believes to represent the pre-degenerated condition. The resultof this manual restoration process is the computer generated 3D restoredbone models 28, wherein the surfaces 24′, 26′ are indicated in anon-degenerated state.

In one embodiment, the above-described bone restoration process isgenerally or completely automated, as disclosed in U.S. patentapplication Ser. No. 12/111,924 to Park, which is entitled Generation ofa Computerized Bone Model Representative of a Pre-Degenerated State andUsable in the Design and Manufacture of Arthroplasty Devices, was filedApr. 29, 2008 and is incorporated by reference in its entirety into thisDetailed Description. In other words, a computer program may analyze thebone models 22 and their degenerated surfaces 24, 26 to determine howand to what extent the degenerated surfaces 24, 26 surfaces on the 3Dcomputer bone models 22 need to be modified to restore them to theirpre-degenerated condition. The computer program then manipulates the 3Ddegenerated surfaces 24, 26 to restore the surfaces 24, 26 to a stateintended to represent the pre-degenerated condition. The result of thisautomated restoration process is the computer generated 3D restored bonemodels 28, wherein the surfaces 24′, 26′ are indicated in anon-degenerated state.

As depicted in FIG. 1C-1, the restored bone models 28 are employed in apre-operative planning (“POP”) procedure to determine saw cut locations30 and drill hole locations 32 in the patient's bones that will allowthe arthroplasty joint implants to generally restore the patient's jointline to its pre-degenerative alignment [block 120].

In one embodiment, the POP procedure is a manual process, whereincomputer generated 3D uni-compartmental implant models 34 (e.g., femurand tibia implants in the context of the joint being a knee) andrestored bone models 28 are manually manipulated relative to each otherby a person sitting in front of a computer 6 and visually observing theuni-compartmental implant models 34 and restored bone models 28 on thecomputer screen 9 and manipulating the models 28, 34 via the computercontrols 11. By superimposing the uni-compartmental implant models 34over the restored bone models 28, or vice versa, the joint surfaces ofthe uni-compartmental implant models 34 can be aligned or caused tocorrespond with the joint surfaces of the restored bone models 28. Bycausing the joint surfaces of the models 28, 34 to so align, theuni-compartmental implant models 34 are positioned relative to therestored bone models 28 such that the saw cut locations 30 and drillhole locations 32 can be determined relative to the restored bone models28.

In one embodiment, the POP process is generally or completely automated.For example, a computer program may manipulate computer generated 3Duni-compartmental implant models 34 (e.g., femur and tibia implants inthe context of the joint being a knee) and restored bone models orplanning bone models 28 relative to each other to determine the saw cutand drill hole locations 30, 32 relative to the restored bone models 28.With reference to the above POP discussion, in one embodiment, 3D modelssuch as those depicted in FIGS. 1F-1M are created by a computer duringPOP. In one embodiment, the femur is planned first. As shown in FIGS.1F-1G, which depict distal axial and posterior coronal views,respectively, the femoral restored bone model 28 and uni-compartmentalfemoral implant model 34 are generated by a computer during POP. As canbe understood from FIGS. 1F-1H, the femoral restored bone model 28 ismoved to the implant model 34 such that the articular surfaces of themodels 28, 34 are superimposed or shape matched. Specifically, asdepicted in FIG. 1I, the femoral restored bone model 28 may be movedsuch that the most posterior point and most distal point of thearticular surface of the restored bone model are aligned relative to theposterior and distal planes that are respectively tangent to the mostposterior point and most distal point of the articular surface of thefemoral implant model 34. The articular surfaces of the implant model 34may then be shape matched or superimposed on the articular surfaces ofthe femur model 28. While this discussion takes place in the context ofthe bone model 28 being moved to the implant model 34, in otherembodiments, the reverse may be true.

As indicated in FIG. 1J, the femur implant model 34 a and the tibiaimplant model 34 b may be shown in a non-implanted state, which may helpthe planner visualize the spatial relationship between the implantmodels 34.

The tibia is planned next. FIG. 1K illustrates the alignment of thetibia bone model 28 b relative to the femoral bone model 28 a, such thatthe femoral condyles are in contact with the tibial plateau. Thisdetermines the rotation of the tibia relative to the femur. Once tibialpositioning is set, the tibial implant model 34 is displayed and changesto the tibial positioning are made to maximize shape matching (FIG. 1L).Sizing and appropriate off-set are accounted for. Then, the implantmodels 34 may be checked for proper alignment, as shown in FIG. 1M.

In summary and regardless of whether via the manual or the substantiallyor totally automated POP process, in one embodiment, theuni-compartmental implant models 34 may be superimposed over therestored bone models 28, or vice versa. In one embodiment, theuni-compartmental implant models 34 are located at point P′ (X_(0-k),Y_(0-k), Z_(0-k)) relative to the origin (X₀, Y₀, Z₀), and the restoredbone models 28 are located at point P (X_(0-j), Y_(0-j), Z_(0-j)). Tocause the joint surfaces of the models 28, 34 to correspond, thecomputer program may move the restored bone models 28 from point P(X_(0-j), Y_(0-j), Z_(0-j)) to point P′ (X_(0-k), Y_(0-k), Z_(0-k)), orvice versa. Once the joint surfaces of the models 28, 34 are in closeproximity, the joint surfaces of the uni-compartmental implant models 34may be shape-matched to align or correspond with the joint surfaces ofthe restored bone models 28. By causing the joint surfaces of the models28, 34 to so align, the uni-compartmental implant models 34 arepositioned relative to the restored bone models 28 such that the saw cutlocations 30 and drill hole locations 32 can be determined relative tothe restored bone models 28.

In one embodiment, once the shape matching is achieved as discussedabove with respect to [block 120], the implant model 34 is modified orpositionally adjusted to achieve the proper spacing between the femurand tibia implants to account for the cartilage thickness notrepresented in the restored bone model 28. To achieve the correctadjustment, an adjustment value T_(r) may be determined. The adjustmentvalue T_(r) that is used to adjust the surface matching may be based offof an analysis associated with the cartilage thickness. In oneembodiment, the minimum cartilage thickness is observed and measured forthe undamaged and damaged femoral condyle. If the greatest cartilageloss is identified on the surface of the healthy condyle, which is themedial condyle in this example, then the lateral condyle can be used asthe cartilage thickness reference for purposes of POP and, morespecifically, for the adjustment value T_(r). Of course, where thelateral condyle is deteriorated and is the target of theuni-compartmental arthroplasty, then the cartilage thickness can bemeasured off of the healthy medial side condyle to determine adjustmentvalue T_(r). Thus, the adjustment value T_(r) may be based on thecartilage thickness measured for the least damaged condyle cartilage.Once the adjustment value T_(r) is determined based off of healthy sidecartilage thickness, the femoral implant model 34 can be positionallyadjusted or otherwise modified relative to the restored bone model 28 toaccount for cartilage thickness to restore the joint line.

A similar adjustment process is also performed for the proximal tibiasuch that the adjustment value T_(r) is determined based off ofcartilage thickness of the healthy side of the proximal tibia and thetibia implant model 34 can be positionally adjusted or otherwisemodified relative to the restored bone model 28 to account for cartilagethickness to restore the joint line.

Thus, as can be understood from [block 123] of FIG. 1C-2, once the shapematching process of the POP in [block 120] has been achieved to alignthe articular surfaces of the implant models 34 relative to thearticular surfaces of the restored bone models 28, the implant models 34may be adjusted relative to the bone models 28 to account for thecartilage thickness not represented in the bone only models 28.Specifically, in one embodiment, the femur implant model 34 or its sawcut plane 30 may be shifted distally relative to the restored femur bonemodel 28 a distance equal to the adjustment value T_(r), which isobtained from the thickness of the healthy side condyle and therebycreating a shifted femur implant model 34′ or shifted saw cut plane 30′[block 123]. Similarly, the tibia implant model 34 or its saw cut plane30 may be shifted distally relative to the restored tibia bone model 28a distance equal to the adjustment value T_(r), which is obtained fromthe thickness of the healthy side condyle and thereby creating a shiftedtibia implant model 34′ or shifted saw cut plane 30′ [block 123]. A moredetailed discussion of the POP procedure is disclosed in U.S.Provisional Patent Application 61/102,692 to Park, which is entitledArthroplasty System and Related Methods, was filed Oct. 3, 2008 and isincorporated by reference in its entirety into this DetailedDescription.

As indicated in FIG. 1E, in one embodiment, once the saw cut planes 30′have been adjusted for the adjustment value T_(r) as set out in [block123], the data 44 regarding the saw cut and drill hole locations 30′, 32relative to point P′ (X_(0-k), Y_(0-k), Z_(0-k)) is packaged orconsolidated as the “saw cut and drill hole data” 44 [block 125]. The“saw cut and drill hole data” 44 is then used as discussed below withrespect to [block 150] in FIG. 1E.

As can be understood from FIG. 1D, the 2D images 16 employed to generatethe bone models 22 discussed above with respect to [block 110] of FIG.1C-1 are also used to create computer generated 3D bone and cartilagemodels (i.e., “arthritic models”) 36 of the bones 18, 20 forming thepatient's joint 14 [block 130] Like the above-discussed bone models 22,the arthritic models 36 are located such that point P is at coordinates(X_(0-j), Y_(0-j), Z_(0-j)) relative to the origin (X₀, Y₀, Z₀) of theX—Y—Z axis [block 130]. Thus, the bone and arthritic models 22, 36 sharethe same location and orientation relative to the origin (X₀, Y₀, Z₀).This position/orientation relationship is generally maintainedthroughout the process discussed with respect to FIGS. 1B-1E.Accordingly, movements relative to the origin (X₀, Y₀, Z₀) of the bonemodels 22 and the various descendants thereof (i.e., the restored bonemodels 28, bone cut locations 30, and drill hole locations 32, althoughnot with respect to the correction of bone cut locations 30, withrespect to adjustment value T_(r) to arrive at the shifted cut locations30′ adjusted for cartilage thickness T_(r)) are also applied to thearthritic models 36 and the various descendants thereof (i.e., theuni-compartmental jig models 38). Maintaining the position/orientationrelationship between the bone models 22 and arthritic models 36 andtheir respective descendants allows the “saw cut and drill hole data” 44to be integrated into the “jig data” 46 to form the “integrated jigdata” 48 employed by the CNC machine 10 to manufacture the customizedarthroplasty jigs 2.

Computer programs for creating the 3D computer generated arthriticmodels 36 from the 2D images 16 include: Analyze from AnalyzeDirect,Inc., Overland Park, Kans.; Insight Toolkit, an open-source softwareavailable from the National Library of Medicine Insight Segmentation andRegistration Toolkit (“ITK”), www.itk.org; 3D Slicer, an open-sourcesoftware available from www.slicer.org; Mimics from Materialise, AnnArbor, Mich.; and Paraview available at www.paraview.org.

Similar to the bone models 22, the arthritic models 36 depict the bones18, 20 in the present deteriorated condition with their respectivedegenerated joint surfaces 24, 26, which may be a result ofosteoarthritis, injury, a combination thereof, etc. However, unlike thebone models 22, the arthritic models 36 are not bone-only models, butinclude cartilage in addition to bone. Accordingly, the arthritic models36 depict the arthroplasty target areas 42 generally as they will existwhen the customized arthroplasty jigs 2 matingly receive thearthroplasty target areas 42 during the arthroplasty surgical procedure.

As indicated in FIG. 1D and already mentioned above, to coordinate thepositions/orientations of the bone and arthritic models 22, 36 and theirrespective descendants, any movement of the restored bone models 28 frompoint P to point P′ is tracked to cause a generally identicaldisplacement for the “arthritic models” 36 [block 135].

As depicted in FIG. 1D, computer generated 3D surface models 40 of thearthroplasty target areas 42 of the arthritic models 36 are importedinto computer generated 3D arthroplasty uni-compartmental jig models 38[block 140]. Thus, the uni-compartmental jig models 38 are configured orindexed to matingly receive the arthroplasty target areas 42 of thearthritic models 36. Jigs 2 manufactured to match such uni-compartmentaljig models 38 will then matingly receive the arthroplasty target areasof the actual joint bones during the arthroplasty surgical procedure.

In one embodiment, the procedure for indexing the uni-compartmental jigmodels 38 to the arthroplasty target areas 42 is a manual process. The3D computer generated models 36, 38 are manually manipulated relative toeach other by a person sitting in front of a computer 6 and visuallyobserving the uni-compartmental jig models 38 and arthritic models 36 onthe computer screen 9 and manipulating the models 36, 38 by interactingwith the computer controls 11. In one embodiment, by superimposing theuni-compartmental jig models 38 (e.g., femur and tibia arthroplasty jigsin the context of the joint being a knee) over the arthroplasty targetareas 42 of the arthritic models 36, or vice versa, the surface models40 of the arthroplasty target areas 42 can be imported into theuni-compartmental jig models 38, resulting in uni-compartmental jigmodels 38 indexed to matingly receive the arthroplasty target areas 42of the arthritic models 36. Point P′ (X_(0-k), Y_(0-k), Z_(0-k)) canalso be imported into the uni-compartmental jig models 38, resulting inuni-compartmental jig models 38 positioned and oriented relative topoint P′ (X_(0-k), Y_(0-k), Z_(0-k)) to allow their integration with thebone cut and drill hole data 44 of [block 125].

In one embodiment, the procedure for indexing the uni-compartmental jigmodels 38 to the arthroplasty target areas 42 is generally or completelyautomated, as disclosed in U.S. patent application Ser. No. 11/959,344to Park, which is entitled System and Method for ManufacturingArthroplasty Jigs, was filed Dec. 18, 2007 and is incorporated byreference in its entirety into this Detailed Description. For example, acomputer program may create 3D computer generated surface models 40 ofthe arthroplasty target areas 42 of the arthritic models 36. Thecomputer program may then import the surface models 40 and point P′(X_(0-k), Y_(0-k), Z_(0-k)) into the uni-compartmental jig models 38,resulting in the uni-compartmental jig models 38 being indexed tomatingly receive the arthroplasty target areas 42 of the arthriticmodels 36. The resulting uni-compartmental jig models 38 are alsopositioned and oriented relative to point P′ (X_(0-k), Y_(0-k), Z_(0-k))to allow their integration with the bone cut and drill hole data 44 of[block 125].

In one embodiment, the arthritic models 36 may be 3D volumetric modelsas generated from the closed-loop process discussed in U.S. patentapplication Ser. No. 11/959,344 filed by Park. In other embodiments, thearthritic models 36 may be 3D surface models as generated from theopen-loop process discussed in U.S. patent application Ser. No.11/959,344 filed by Park.

In one embodiment, the models 40 of the arthroplasty target areas 42 ofthe arthritic models 36 may be generated via an overestimation processas disclosed in U.S. Provisional Patent Application 61/083,053, which isentitled System and Method for Manufacturing Arthroplasty Jigs HavingImproved Mating Accuracy, was filed by Park Jul. 23, 2008, and is herebyincorporated by reference in its entirety into this DetailedDescription.

As indicated in FIG. 1E, in one embodiment, the data regarding theuni-compartmental jig models 38 and surface models 40 relative to pointP′ (X_(0-k), Y_(0-k), Z_(0-k)) is packaged or consolidated as the “jigdata” 46 [block 145]. The “jig data” 46 is then used as discussed belowwith respect to [block 150] in FIG. 1E.

As can be understood from FIG. 1E, the “saw cut and drill hole data” 44is integrated with the “jig data” 46 to result in the “integrated jigdata” 48 [block 150]. As explained above, since the “saw cut and drillhole data” 44, “jig data” 46 and their various ancestors (e.g., models22, 28, 36, 38) are matched to each other for position and orientationrelative to point P and P′, the “saw cut and drill hole data” 44 isproperly positioned and oriented relative to the “jig data” 46 forproper integration into the “jig data” 46. The resulting “integrated jigdata” 48, when provided to the CNC machine 10, results in jigs 2: (1)configured to matingly receive the arthroplasty target areas of thepatient's bones; and (2) having cut slots and drill holes thatfacilitate preparing the arthroplasty target areas in a manner thatallows the arthroplasty joint implants to generally restore thepatient's joint line to its pre-degenerated state or natural alignmentstate.

As can be understood from FIGS. 1A and 1E, the “integrated jig data” 44is transferred from the computer 6 to the CNC machine 10 [block 155].Jig blanks 50 are provided to the CNC machine 10 [block 160], and theCNC machine 10 employs the “integrated jig data” to machine thearthroplasty jigs 2 from the jig blanks 50.

The remainder of this Detailed Description will now discuss examplecustomized arthroplasty uni-compartmental cutting jigs 2 capable ofbeing manufactured via the above-discussed process in addition tomethods of using the jigs 2. While, as pointed out above, theabove-discussed process may be employed to manufacture jigs 2 configuredfor arthroplasty procedures involving knees, elbows, ankles, wrists,hips, shoulders, vertebra interfaces, etc., the jig examples depicted inFIGS. 2A-18B are for partial knee (“uni-compartmental”) replacementprocedures. Thus, although the discussion provided herein is given inthe context of uni-compartmental jigs and the generation thereof, thisdisclosure is readily applicable to total arthroplasty procedures in theknee or other joint contexts. Thus, the disclosure provided hereinshould be considered as encompassing jigs and the generation thereof forboth total and uni-compartmental arthroplasty procedures.

For a discussion of a femur arthroplasty jig 2 a, reference is firstmade to FIGS. 2A-2E. FIGS. 2A-2B are isometric views of the femurarthroplasty jig 2 a in a customized state, wherein the jig 2A is showneither on (FIG. 2A) or off (FIG. 2B) the distal femur 100. FIGS. 2C-2Ddepict isometric top, bottom and side views of the femur arthroplastyjig 2 a, wherein the femur 100 is not shown, the jig 2 a being in acustomized state. FIG. 2E is a side-top isometric view of the jig 2 a ina non-customized state or, in other words, in the form of a jig blank 50a from which the jig 2 a is manufactured.

As shown in FIGS. 2A-2E, a femur arthroplasty jig 2 a may include aninterior side or portion 200 and an exterior side or portion 202. Whenthe femur cutting jig 2 a is used in a UKA procedure, the interior sideor portion 200 faces and matingly receives the arthroplasty target area42 of the femur lower end, and the exterior side or portion 202 is onthe opposite side of the femur cutting jig 2 a from the interior portion200.

As can be best understood from FIGS. 2B and 2D, the interior side 200may include an anterior flange 107, a mid section 104, a distal cut slot111, a distal drill hole 112, an antero-medial section 109, and a targetarea 125. In some embodiments, the target area 125 may include ananterior mating surface 103 and a distal condylar mating surface 105.The anterior mating surface may include a hooking portion 113. Theinterior portion 200 of the femur jig 2 a is configured to match thesurface features of the damaged lower end (i.e., the arthroplasty targetarea 42) of the patient's femur 18. Thus, when the arthroplasty targetarea 42 is received in the target area 125 of the interior portion 200of the femur jig 2 a during the UKA surgery, the surfaces of the targetarea 42 and the target area 125 of the interior portion 200 of the jig 2a match.

The surface of the interior portion 200 of the femur cutting jig 2A ismachined or otherwise formed into a selected femur jig blank 50A and isbased or defined off of a 3D surface model 40 of a target area 42 of thedamaged lower end or target area 42 of the patient's femur 18.

As shown in FIGS. 2A, 2C and 2E, the exterior side 202 of the jig 2 amay include an anterior flange 107, an anterior-distal condylar section102 and a posterior-distal condylar section 106, a lateral edge 108, amid section 104, a distal cut slot 111, a distal drill hole 112, and anantero-medial section 109. In some embodiments, the exterior side mayalso include a cut slot extension 110 for a close slot. The interiorside 200 and the exterior side 202 help the jig 2 a to mate stably andaccurately to the distal femur, thereby accurately positioning thedistal cut slot 111 that will be used to guide the distal cut of themedial condyle. The jig 2 a also incorporates one or more distal drillholes 112 that may guide the positioning of a secondary cutting guide or“chamfer” block. This subsequently creates the cuts that will determinethe flexion/extension, internal/external, anterior/posterior,distal/proximal position of the UKA implant. The medial/lateral positionis left open.

For a discussion of certain sizing measurements that may be utilized inthe development of the femur cutting jig 2 a, reference is now made toFIGS. 3A-3C. FIG. 3A illustrates how the femur arthroplasty jig 2 a ofFIG. 2A may be sized based on the medial condyle. FIG. 3B illustratesthe area in the trochlear groove and the anterior cortex that may becovered by the jig 2 a of FIG. 2A. FIG. 3C illustrates how the size ofthe anterior flange 107 of the jig 2 a of FIG. 2A may be determined.

The size of the femoral jig 2 a depends on the size of each particularpatient's bone. In one embodiment, as shown in FIGS. 3A-3C, theanterior-distal and posterior-distal condylar section 102,106 may bedesigned to reach within a distance D₁ and D₂ of approximately 2-3 mm ofthe medial and lateral ends of the medial condyle, and to reach within adistance D₃ of approximately 3-5 mm of the posterior condyle as shown inFIG. 3A. The mid section 104 should reach to within a distance D₄ ofapproximately 3-5 mm to the lateral side of the bottom of the trochleargroove as shown in FIG. 3B. The medial edge of the antero-medial section109 should line up with a line c1 drawn from the middle of the medialcondyle as shown in FIG. 3B. In one embodiment, the anterior flange 107may have a thickness T₁ of approximately 5 mm or less and the top of theanterior flange 107 should have a length L₁ of approximately 0.8-1.2 mmof the target area as shown in FIG. 3C. In one embodiment, the thicknessT₁ is 4 mm. The cut slot 111 may be positioned according to the positionof the femoral implant, as described in more detail above.

For a discussion of the mating surfaces for the femur arthroplasty jig 2a, reference is now made to FIGS. 4-10. FIGS. 4A and 4B display oneembodiment of the mating surfaces for the arthroplasty femur jig 2 aabout the distal femoral condyle. FIGS. 5A and 5B display an embodimenthaving a reduced number of mating surfaces that still provides adequatestability of the arthroplasty femur jig 2 a about the distal femoralcondyle 350. FIG. 6 is an isometric view of the arthroplasty femur jig 2a with mating surfaces corresponding to those of the distal femoralcondyle 350 depicted in FIGS. 4A and 4B. FIG. 7 illustrates mating andhooking of the anterior flange 107 of the arthroplasty femur jig 2 aabout the edge of the anterior-proximal trochlear groove. FIG. 8illustrates one method of mating 331 to the trochlear groove. FIG. 9illustrates full mating 332 of the trochlear groove. FIG. 10 illustratesa single MRI slice 355 in the sagittal plane with three consecutivesegmentation outlines where the corresponding outline hooks the edge ofthe anterior-proximal trochlear groove.

In one embodiment (FIGS. 4A and 4B), mating of the arthroplasty femurjig 2 a occurs on the surfaces of the distal femur at the medial condyle302, 303, the anterior cortex 310, 311, 313, into the trochlear groove305, 306, 308, 309, and about the edge 314 of the anterior-proximaltrochlear groove 307. In this embodiment, the combination of thesesurfaces serve as a condition that provides for reliable mating giventhe variety of patient bone anatomies. Specific mating surfaces areillustrated in FIGS. 4A and 4B with double cross-hatching illustratingdiscrete mating surfaces and single cross-hatching illustrating optionaloverall mating areas that may circumscribe or encompass the morediscrete mating surfaces. These surfaces are defined as follows: thedistal medial condyle 302, the anterior medial condyle 303, the medialanterior cortex 310, and the anterior cortex 311, 313, the distal medialtrochlear groove 305, the antero-medial trochlear groove 308, and aportion 309 of the distal lateral trochlear groove and theantero-lateral trochlear groove that extends 5-6 mm lateral to thesulcus of the trochlear groove. The arthroplasty femur jig 2 a mayeither mate to these surfaces specifically (as indicated by the doublecross-hatching) or globally (as indicated by the single cross-hatching).For example, on the surfaces of the trochlear groove 307 and the medialcondyle 301, the jig 2 a could either mate to surfaces 302, 303, 305,306, 308, 309 or globally to the area circumscribing these surfaces 304,which is illustrated with single cross-hatching. On the anterior cortex,the jig 2 a could either mate to surfaces 310, 311, 313 or to the areacircumscribing these areas 312.

As can be understood from FIG. 4A, the distal medial condyle 302includes a distal semi-planar region of the articular surface of themedial condyle 301. The posterior edge of the distal medial condyle 302begins where the articular surface of the medial condyle 301 begins tosignificantly curve towards a posterior region of the articular surfaceof the medial condyle 301, and the anterior edge of the distal medialcondyle 302 begins where the articular surface of the medial condyle 301begins to significantly curve towards the anterior medial condyle region303 of the medial condyle 301.

The anterior medial condyle 303 includes an anterior region of thearticular surface of the medial condyle 301. The posterior edge of theanterior medial condyle 303 begins where the articular surface of themedial condyle 301 begins to significantly curve towards the distalmedial condyle 302 of the articular surface of the medial condyle 301,and the lateral edge of the anterior medial condyle 303 begins where thearticular surface of the medial condyle 301 begins to significantlycurve towards or transition into the medial region of the trochleargroove 307.

The distal medial trochlear groove 305 includes a distal-medial regionof the articular surface of the trochlear groove 307. The medial edge ofthe distal medial trochlear groove 305 begins where the articularsurface of the trochlear groove 307 begins to significantly curve ortransition into the anterior medial condyle 303 of the articular surfaceof the medial condyle 301, and the lateral edge of the distal medialtrochlear groove 305 begins where the articular surface of the trochleargroove 307 begins to curve out of or transition from the deepest portionof the trochlear groove 307.

The distal lateral trochlear groove 306 includes a distal-lateral regionof the articular surface of the trochlear groove 307. The medial edge ofthe distal lateral trochlear groove 306 begins where the articularsurface of the trochlear groove 307 begins to significantly curve ortransition into the deepest portion of the trochlear groove 307, and thelateral edge of the distal lateral trochlear groove 306 begins where thearticular surface of the trochlear groove 307 begins to curve ortransition into the articular surface of the lateral condyle.

As can be understood from FIG. 4A, the antero-medial trochlear groove308 includes an anterior-medial region of the articular surface of thetrochlear groove 307. The antero-medial trochlear groove 308 is locatedbetween the anterior patellar facet boarder 314 and the distal medialtrochlear groove 305. The lateral edge of the antero-medial trochleargroove 308 begins where the articular surface of the trochlear groove307 begins to curve out of or transition from the deepest portion the oftrochlear groove 307.

The antero-lateral trochlear groove 309 includes an anterior-lateralregion of the articular surface of the trochlear groove 307. Theantero-lateral trochlear groove 309 is located between the anteriorpatellar facet boarder 314 and the distal lateral trochlear groove 306.The lateral edge of the antero-lateral trochlear groove 309 begins wherethe articular surface of the trochlear groove 307 begins to curve ortransition into the articular surface of the lateral condyle.

As indicated in FIG. 4A by the single cross-hatching, the overallanterior cortex or anterior optimal target region 312 is located on theanterior shaft of the femur proximal of the patellar facet boarder 314.The anterior optimal target region 312 may be generally coextensive withthe generally planar surface area on the anterior shaft of the femurbetween the articularis genu 1000 and the patellar facet boarder 314.The region 312 may extend from a medial edge generally even with a lineextending distally-proximally through the medial condyle to a lateraledge generally even with a line extending distally-proximally throughthe most lateral edge of the transition between the trochlear groove andthe lateral condyle surface. The most distal edge of the region 312 maycontact the patellar facet boarder 314 at discrete locations or points329, 333. For example, a discrete point of contact with the patellarfacet boarder 314 may be at a point 329 generally even with a lineextending distally-proximally with the deepest portion of the trochleargroove. Another discrete point of contact with the patellar facetboarder 314 may be at a point 333 generally even with a line extendingdistally-proximally with a location half way through the transitionbetween the trochlear groove and the lateral condyle surface.

As indicated in FIG. 4A by the double cross-hatching, multiple discretetarget regions 310, 311, 313 may be identified within the overallanterior cortex or anterior optimal target region 312. Thus, althoughthe anterior optimal target region 312 may be generally coextensive withthe generally planar surface area on the anterior shaft of the femurbetween the articularis genu 1000 and the patellar facet boarder 314,the actual areas 310, 311, 313 within the anterior optimal target region314 identified as being a reliable surface for the generation of themating surfaces of arthroplasty jigs may be limited to any one or moreof the areas 310, 311, 313. For example, an anterior-medial targetregion 310 forms a most medial discrete region within the overall region312. The anterior-medial region 310 has a medial edge generally evenwith a line extending distally-proximally through the medial condyle,and a proximal edge generally even with a line extendingdistally-proximally through the transition between the medial condyleand the trochlear groove.

An anterior-center-medial target region 311 forms a central/medialdiscrete region within the overall region 312 just lateral of the region310. The anterior-center-medial region 311 has a medial edge generallyeven with a line extending distally-proximally through the transitionbetween the medial condyle and the trochlear groove, and a lateral edgegenerally even with a line extending distally-proximally through thedeepest portion of the trochlear groove.

An anterior-lateral target region 313 forms a lateral discrete regionwithin the overall region 312 just lateral of the region 311. Theanterior-lateral region 313 has a medial edge generally even with a lineextending distally-proximally through the deepest portion of thetrochlear groove, and a lateral edge generally even with a lineextending distally-proximally through the transition between thetrochlear groove and the lateral condyle surface.

In another embodiment (FIGS. 5A and 5B), mating of the arthroplastyfemur jig 2 a occurs on the surfaces of the medial condyle 302, 303,305, 308, the anterior-center-medial region 311, and about the anterioredge 314 of the anterior-proximal trochlear groove 307, each of theseregions 302, 303, 305, 308 and 311 being substantially as describedabove with respect to FIGS. 4A-4B. This embodiment differs from that ofFIGS. 4A and 4B in that the anterior shaft region 312 does not reach asfar laterally or medially, and the medial condyle—trochlear grooveregion 304 the lateral portion of the trochlear groove. The method ofmating for each of these embodiments is performed similarly and will beexplained later.

For each of these embodiments, overestimating is performed at the rim314 of articular cartilage, except at, for example, two points 329, 333(FIG. 7), although in some embodiments it may be less than or greaterthan two points. “Hooking” occurs at the edge 314 of theanterior-proximal trochlear groove 307 instead of mating. “Hooking” isperformed by matching, for example, two or more points 329, 333 to therim of the articular cartilage as illustrated in FIG. 7, which shows asliced section 330 of the femoral jig 2 a where mating at the anteriorsurface occurs. Between hooking points 329, 333, the jig 2 a is designedto overestimate the area, which is where there may be osteophytes orcartilage. The purpose of hooking to single points while overestimatingother areas is to avoid mis-matching due to the unpredictable nature ofosteophytes. In one embodiment, the anterior mating surface with hookingpoints incorporated is shown by the double cross-hatch section 328. Asillustrated in FIG. 7, hooking occurs in a manner that steps down andhooks at another point. FIG. 10 illustrates this process duringsegmentation of the femur in the sagittal plane. In the active slice n,the segmentation line matches nearly precisely to the edge of theanterior-proximal trochlear groove. The segmentation line of slice n+1is overestimated, while that of n−1 is nearly identical to thesegmentation line of slice n. Between hooking points, at least one slicemust be overestimated. The ideal edge to hook is illustrated in FIG. 10.The ideal edge protrudes from the anterior cortex at least 1 mm. Oncesegmentation is complete, the mating surface should resemble that ofFIG. 7. For example, as shown in FIG. 6, hooking points 323, whichcorrespond to points 329, 333 of the anterior-proximal edge of thetrochlear groove, hook on points 329, 333.

A detailed discussion of the overestimation process is provided in U.S.Provisional Patent Application 61/083,053, which is entitled System andMethod for Manufacturing Arthroplasty Jigs Having Improved MatingAccuracy, was filed by Park Jul. 23, 2008, and is hereby incorporated byreference in its entirety into this Detailed Description.

Mating in the trochlear groove can be achieved with two differentmethods. In one method, mating 332 would be absolute as illustrated inFIG. 9. However, due to the drastic deflection at the trochlear grooveof some femurs, absolute mating may not be reliable. For these cases,mating 331 may be done step-wise, as illustrated in FIG. 8. In thismethod, every other segmentation slice is matched precisely to thetrochlear groove, while those in between are over-estimated.Segmentation is done in a similar manner to that described above and asillustrated for hooking in FIG. 10. To determine whether slices shouldbe overestimated, segmentation in the trochlear groove may first beperformed absolute with each slice matching the surface. Thereafterconsecutive slices may be compared (slice n compared with slice n+1), ifthe distance between slices is greater than 1 mm, then the next slice(n+1) may be adjusted to reduce this distance, thereby overestimatingthe next slice (n+1). By overestimating this next slice (n+1), thefollowing slice (n+2), can mate precisely to the trochlear groovewithout under-estimating the trochlear groove. Mating of the trochleargroove is generally performed as a combination of these methods.

As described above and can be understood from FIG. 6, the femur jig 2 amay include a distal condylar mating region 316, trochlear groove matingregion 320 and an anterior cortex mating region 326. The mating regionsor surfaces 316, 320, 326 of the arthroplasty femur jig 2 a thatcorrespond and mate specifically to the surfaces defined above withrespect to FIGS. 4A-5B are illustrated in FIG. 6. In general, surface315 mates to the distal medial condyle 302, surface 317 mates to theanterior medial condyle 303, surface 318 mates to the distal medialtrochlear groove 305, surface 321 mates to the antero-medial trochleargroove 308, surface 319 mates to the distal lateral trochlear groove306, surface 322 mates to the antero-lateral trochlear groove 309,surface 327 mates to the medial anterior cortex 310, surfaces 325 and324 mate to the anterior cortex 311 and 313, respectively, and points323 hook onto the edge 314 of the anterior-proximal trochlear groove 307at points 329, 333.

As can be understood from the proceeding discussion regarding the matingcontact surfaces (indicated by single and double cross hatch regions inFIGS. 4A-4B and 5A-5B) of the distal femur and the corresponding matingcontact surfaces (indicated by single and double cross hatch regions inFIG. 6) of the inner side of the uni-compartmental arthroplasty jig, theinner side of the jig matingly receives the arthroplasty target regionof the distal femur as shown in FIG. 2A. However, although the innerside of the femoral jig matingly receives the arthroplasty target regionof the distal femur, only those mating contact regions (indicated bysingle and double cross hatch regions in FIG. 6) of the inner side ofthe jig actually make mating contact with the mating contact regions(indicated by single and double cross hatch regions in FIGS. 4A-4B and5A-5B) of the distal femur. All other regions (those regions not singleor double cross hatched in FIG. 6) of the inner side of the jig do notmake contact with corresponding surfaces of the distal femur on accountof being defined according to the overestimation process. Thus, in oneembodiment, the double cross hatch regions of the inner side of the jigand the distal femur may be the only regions that make mating contactbecause the rest of the inner side of the jig is the result of theoverestimation process. In another embodiment, both the single anddouble cross hatch regions of the inner side of the jig and the distalfemur may be the only regions that make mating contact because the restof the inner side of the jig is the result of the overestimationprocess. Regardless, the inner side of the jig is configured to matinglyreceive the distal femur such that the jig has a customized matingcontact with the distal femur that causes the jig to accurately andsecurely sit on the distal femur in a stable fashion such that the jigmay allow the physician to make the distal cut with an accuracy thatallows the femoral implant to restore the patient's joint to itspre-degenerated or natural alignment state. This accurate and stablecustomized mating between the jig and femur is facilitated by the jigmating contact regions being based on regions of the femur that areaccurately identified and reproduced from the medical imaging (e.g.,MRI, CT, etc.) used to generate the various bone models, andoverestimating in those regions that are not accurately identified andreproduced due to issues with the medical imaging and/or the inabilityto machine the identified bone features into the inner side of the jig.

For a discussion of the tibia arthroplasty jig 2 b, reference is firstmade to FIGS. 11A-11E. FIGS. 11A-11B are isometric views of the tibialarthroplasty jig 2 b in a customized state, wherein the jig is shown on(FIG. 11A) or off (FIG. 11B) the proximal tibia 20. FIGS. 11C-11E depicttop and bottom views of the tibial arthroplasty jig 2 b in a customizedstate, wherein the tibia is not shown. FIG. 11E shows a top view of thejig 2 b of FIG. 11C, wherein the jig 2 b is in a non-customized state(e.g., the jig 2 b is in the form of a jig blank 50 b from which the jig2 b is created machining or other manufacturing methods).

As indicated in FIGS. 11A-11E, a tibia arthroplasty jig 2 b may includean interior side or portion 404 and an exterior side or portion 406.When the tibia cutting jig 2 b is used in a UKA procedure, the targetarea 438 of the interior side or portion 404 faces and matingly receivesthe arthroplasty target area 42 of the tibia proximal end, and theexterior side or portion 406 is on the opposite side of the tibiacutting jig 2 b from the interior portion 404.

As may be best understood with reference to FIG. 11D, the interiorportion 404 of the tibia cutting jig 2 b may include a horizontal cutclot 433, a proximal drill hole 432, a target area 438, and matingportions 434, 435, 436, 437. The interior portion 404 of the tibia jig 2b is configured to match the surface features of the damaged proximalend (i.e., the arthroplasty target area 42) of the patient's tibia 20.Thus, when the target area 42 is received in the interior portion 404 ofthe tibia jig 2B during the UKA surgery, the surfaces of the target area42 and interior portion 404 matingly match.

The surface of the interior portion 404 of the tibia cutting jig 2 b ismachined or otherwise formed into a selected tibia jig blank 50B and isbased or defined off of a 3D surface model 40 of a target area 42 of thedamaged upper end or target area 42 of the patient's tibia 20.

As indicated in FIGS. 11A-11C and 11E, the exterior portion 406 of thetibial jig 2 b may include a medial plateau portion 428, an anteriorcortex flange 429, a medial anterior cortex portion 431, a medial tibialupslope portion 430, a horizontal cut clot 433, a proximal drill hole432, and finally a target area 438. As can be understood from FIG. 11E,in a non-customized state, the jig 2 b may include a customizableportion 440 which may be customized to help properly position the jig 2b during surgery. Thus, together with the features of the interiorportion 404 of the jig 2 b, the exterior portion 406 helps the jig 2 bto mate stably with the medial tibia 426 and position a drill hole 432and horizontal cut slot 433. With this drill hole and horizontal cutslot, the proximal/distal, internal/external, varus/valgus positions ofthe uni-condylar tibial implant may be set.

For a discussion of certain sizing measurements that may be utilized inthe development of the tibial cutting jig 2 b, reference is now made toFIGS. 12A-12B. FIG. 12A illustrates the coverage of the tibial plateauthat one embodiment of the tibial jig 2 b may cover. FIG. 12Billustrates the height of one embodiment of the tibial jig 2 b.

The size of the tibial jig 2 b is determined by the size of thepatient's bone 20. FIG. 12A illustrates the parameters which determinehow much of the tibial plateau the jig 2 b should cover. In oneembodiment, the medial edge of the tibial plateau portion 428 of thetibial jig 2 b has a distance D_(m) of approximately 1-2 mm from themedial edge of the tibial plateau. Also, the posterior edge of thetibial plateau portion 428 of the tibial jig 2 b has a distance D_(p) ofapproximately 3-5 mm from the posterior edge of the tibial plateau. Inone embodiment as depicted in FIG. 12A, the anterior cortex flange 429should not reach further than midway past the patellar insertion asillustrated by line c2. In one embodiment as shown in FIG. 12B, thelength L_(t) the jig 2 b between the top surface of the jig 2 b and thebottom edge of the medial anterior cortex portion 431 is approximately40 mm. The horizontal cut slot 433 should be positioned at the levelwhich the proximal/distal and varus/valgus positions of the unicondylartibial implant should be set.

For a discussion of the mating surfaces for the tibial arthroplasty jig2 b, reference is now made to FIGS. 13A-18B. FIGS. 13A and 13B are,respectively, an anterior coronal view and a proximal axial view of oneembodiment of the mating surfaces for the tibial arthroplasty jig 2 b onthe proximal tibia 20. FIGS. 14A-14B are, respectively, an anteriorcoronal view and a proximal axial view of a second embodiment of themating surfaces for the tibial arthroplasty jig 2 b on the proximaltibia 20. FIG. 15 illustrates the tibial arthroplasty jig 2 b withmating surfaces corresponding to those of the proximal tibia depicted inFIGS. 13A-13B. FIG. 16 is a single MRI slice in the sagittal plane atthe medial upslope of the intercondyloid eminence. FIGS. 17A-18Billustrate various methods of the tibial arthroplasty jig 2 b matingwith the medial upslope 602 of the intercondyloid eminence 600.

The tibial arthroplasty jig 2 b mates to the medial surfaces of theproximal tibia 20. In one embodiment, for stability, the guide 2 b mayat least mate to the surfaces that are illustrated in FIG. 13A-13B.FIGS. 14A-14B illustrates another embodiment of the mating conditionsthat lead to stability. Both of these embodiments incorporate some orall of the areas illustrated by the double cross hatch markings 534,535, 536, 537 and 538 in FIGS. 13A-14B. These areas are: the medialtibial plateau 534, the medial anterior tibial cortex 537, the anteriorcortex 538 superior to the tuberosity 555, the medial upslope 535 of theintercondyloid eminence 556, and a region 536 extending from anteriorthe intercondyloid eminence 556 to towards the tuberosity 555 over theedge transition from the tibial plateau region (FIG. 13A) to the tibialanterior region (FIG. 13B). In one embodiment, the tibial arthroplastyjig 2 b may include mating surfaces that matingly engage some or all ofthese discrete areas 534, 535, 536, 537, 538 or mating surfaces of thejig 2 b may matingly engage more globally the discrete mating surfaces534, 535, 536, 537, 538 and the surrounding areas 533, 539, 549 asillustrated with the single hatch markings in FIGS. 13A-14B.Specifically, the jig 2 a may have mating surfaces that matingly engagethe region of the tibia encompassed by the single hatch area 539 on thetibial plateau and single hatch area 540 on the anterior region of theproximal tibia, as reflected in FIGS. 14A-14B, or the single hatch area533 which extends over the tibial plateau and anterior region of theproximal tibia, as illustrated in FIGS. 13A-13B.

As shown in FIGS. 13A and 13B by the cross-hatching, the optimal targetregion 533 on the anterior side of the tibial shaft may be divided intotwo sub-regions 537 and 538. The first or medial sub-region 537 may be agenerally planar surface region that extends distally from generally theplateau edge or capsule line to a point generally even with thebeginning of the distal half to distal third of the tibial tuberosity555. The sub-region 537 may extend medial-lateral from the medial edgeof the medial tibia condyle to a point generally even with a medial edgeof the tibial tuberosity 555.

The center sub-region 538 may be a generally planar surface region thatextends distally from generally the plateau edge or capsule line to apoint near the proximal boundary of the tibial tuberosity 555. Thecenter sub-region 538 may extend medial-lateral from the lateral edge ofthe medial sub-region 537 to a point generally even with a center of thetibial tuberosity 555 or even to the lateral edge of the tibialtuberosity 555.

To result in a jig 2 a having mating surfaces that only matingly engageor contact some or all of the above-discussed surfaces of the tibia 20,overestimation during the segmentation process may be employed toover-machine those areas of the jig 2 a that correspond to thosesurfaces of the tibia 20 that are outside the double cross hatchedregions and/or the single cross hatched regions depicted in FIGS.13A-14B. The result of such an overestimation process is a jig 2 a doesnot make contact with those regions of the tibia 20 that are outside thedouble and/or single cross hatch regions of the tibia 20, the jig 2 aonly making mating, secure and stable contact with the double crosshatch, single cross hatch, combinations thereof, or portions thereof.

In the other embodiment as illustrated in FIGS. 13A and 13B, oneadditional mating area 536 may be the ridge superior to the tuberosityand anterior to the intercondyloid eminence 556 where insertion of theACL takes place. At this ridge there may be irregular osteophytes asshown in FIG. 16. Mating in this area may help to stabilizeinternal/external rotation. Because of the irregularity of osteophytesin this region, mating here may not be absolute. Segmentation may “hug”this region as shown in FIG. 16. Between slices, segmentation may takecare to over-estimate in order not to segment too closely and causerocking of the jig.

In some embodiments, mating at the medial upslope 535 of theintercondyloid eminence 556 may be necessary to stabilizeinternal/external rotation. Because of the rapid change in geometry atthe up slope, to facilitate accurate mating at this location 535,overestimation may be performed to prevent mismatching. FIGS. 17A-18Billustrate two methods of mating to the medial upslope 557 of theintercondyloid eminence 556. FIGS. 17B and 18B illustrate an enlargedview of the upslope 557 in a coronal plane. In one method as depicted inFIG. 18B, mating may be absolute and sequential segmentation lines inthe sagittal plane may be drawn to mate precisely to the cartilagesurface of the upslope 557 of the intercondyloid eminence 556. Sincesegmentation slices in the sagittal plane are drawn 2 mm apart from oneanother, interpolation between slices may not represent the geometry ofthe upslope. This first method may be performed if in checkingsequential slices, the distance between slices is not greater than 1 mm.Otherwise, the method illustrated in FIGS. 17A-17B may be performed tosegment the upslope of the tibial spine. In one embodiment of thismethod, at least one segmentation slice 550 (see FIG. 16) in thesagittal plane should mate precisely to the medial upslope of theintercondyloid eminence. Slices between this mating slice and thoseslices that mate to the medial plateau may be overestimated. As aresult, the upslope mating region 535 may be as indicated in FIG. 17B,the rest of the upslope 557 being overestimated so no other contactbetween the jig 2 a and upslope 557 occurs, other than at region 535(compare FIG. 18B at 557 for example of no overestimation and FIG. 17Bat 557 for example of overestimation).

As can be understood from FIGS. 13A and 13B, the proximal tibia 20includes a general mating area 533 that extends over or incorporatesareas 536, 537, 538 of the tibial anterior region near the tibialplateau (FIG. 13A) and areas 534, 535, 536 of the tibial plateau itself(FIG. 13B), the general mating area 533 being identified in FIGS. 13Aand 13B via a single cross hatch and including the double hatch regions534, 535, 536, 537, 538 encompassed by the single cross hatch. Asillustrated in FIGS. 14A and 14B, in another embodiment, a generalmating area extends over areas 534, 535 of the medial tibial plateau 539(FIG. 14B), and a general mating area over areas 537, 538 of the medialanterior cortex 540 (FIG. 14A), each of the regions 539, 540 beingidentified by single cross-hatch markings and including the double hatchregions 534, 535, 537, 538 encompassed by the single cross hatch.

As can be understood from FIG. 15, the tibial jig 2 b includes a generalmating area 543 (FIG. 15), which is identified by single cross-hatchmarkings and defined in the inner surface 438 of the jig 2 b (see FIGS.11B and 11D). The surfaces within the target area 438 of the tibialarthroplasty jig 2 b that mate to corresponding surfaces of the tibia 20are illustrated by the double cross hatch markings in FIG. 15. Areasthat are outside the single cross hatch markings 543 may not mate withthe corresponding surfaces of the proximal tibia and are overestimated.Specifically, the corresponding surfaces within the tibial arthroplastyjig 2 b target area 438 that mate with the proximal tibia 20 are thefollowing: surface 546 matingly contacts the medial plateau 534, surface545 matingly contacts the medial upslope 535 of the intercondyloideminence 556, surface 544 matingly contacts the region 536 thatincorporates the ridge superior to the tuberosity 555 and anterior tothe intercondyloid eminence 556, surface 541 matingly contacts theanterior cortex 538 superior to the tuberosity 555, and surface 542matingly contacts the medial anterior cortex 537. The single cross hatchregion 543 of the mating target region 438 of the jig 2 b may, dependingon the embodiment, be configured to matingly contact the single crosshatch regions 533, 539, 540 shown in FIGS. 13A-14B. Alternatively, ifthe image slices are not sufficiently narrow or the topography of thetibia 20 does not lend itself to accurate mating replication for the jig2 a, the regions 533, 539, 540 may be near, but slightly offset from thecorresponding surfaces 533, 539, 540 of the tibia 20 due tooverestimation, the regions 541, 542, 544, 545 and 546 being the onlyportions of the jig 2 a that actually matingly contact the correspondingregions 534, 535, 536, 537 and 538 of the tibia 20.

As can be understood from the proceeding discussion regarding the matingcontact surfaces (indicated by single and double cross hatch regions inFIGS. 13A-14B) of the proximal tibia 20 and the corresponding matingcontact surfaces (indicated by single and double cross hatch regions inFIG. 15) of the inner side 438 of the uni-compartmental arthroplasty jig2 b, the inner side 438 of the jig 2 b matingly receives thearthroplasty target region 42 of the proximal tibia 2 b as shown in FIG.11A. However, although the inner side 438 of the tibia jig 2 b matinglyreceives the arthroplasty target region 42 of the proximal tibia 20,only those mating contact regions (indicated by single and double crosshatch regions in FIG. 15) of the inner side of the jig actually makemating contact with the mating contact regions (indicated by single anddouble cross hatch regions in FIGS. 13A-14B) of the proximal tibia. Allother regions (those regions not single or double cross hatched in FIG.15) of the inner side of the jig do not make contact with correspondingsurfaces of the proximal tibia on account of being defined according tothe overestimation process. Thus, in one embodiment, the double crosshatch regions of the inner side of the jig and the proximal tibia may bethe only regions that make mating contact because the rest of the innerside of the jig is the result of the overestimation process. In anotherembodiment, both the single and double cross hatch regions of the innerside of the jig and the proximal tibia may be the only regions that makemating contact because the rest of the inner side of the jig is theresult of the overestimation process. Regardless, the inner side of thejig is configured to matingly receive the proximal tibia such that thejig has a customized mating contact with the proximal tibia that causesthe jig to accurately and securely sit on the proximal tibia in a stablefashion such that the jig may allow the physician to make the proximalcut with an accuracy that allows the tibia implant to restore thepatient's joint to its pre-degenerated or natural alignment state. Thisaccurate and stable customized mating between the jig and tibia isfacilitated by the jig mating contact regions being based on regions ofthe tibia that are accurately identified and reproduced from the medicalimaging (e.g., MRI, CT, etc.) used to generate the various bone models,and overestimating in those regions that are not accurately identifiedand reproduced due to issues with the medical imaging and/or theinability to machine or otherwise manufacture the identified bonefeatures into the inner side of the jig.

The discussion provided herein is given in the context ofuni-compartmental jigs and the generation thereof. However, thedisclosure provided herein is readily applicable to total arthroplastyprocedures in the knee or other joint contexts. Thus, the disclosureprovided herein should be considered as encompassing jigs and thegeneration thereof for both total and uni-compartmental arthroplastyprocedures. Additionally, while the discussion is given in the contextof restoring the patient to their natural alignment, the concepts taughtherein are also readily applicable to arthroplasty procedures causingthe patient's knee to be zero mechanical axis. Thus, the disclosurecontained herein should be considered to encompass both naturalalignment and mechanical axis alignment. Additionally, the discussionprovided herein is given in the context of medial uni-compartmental kneejigs but the teachings are equally applicable to lateraluni-compartmental knee jigs; therefore the disclosure should beconsidered to encompass both medial and lateral uni-compartmental kneejigs.

For an overview of an embodiment of the above-described methods ofdesign, manufacture and use of the above-described arthroplasty jigsthat may be utilized in a UKA procedure, reference is made to FIG. 19,which is a flow chart illustrating the methods. As shown in FIG. 19, thetarget bones are scanned and the resulting images are segmented [blocks702 and 704]. The resulting segmented images are used to form 3D modelsof the target bones. The 3D models of the target bones are employed forthe surgical planning of the jigs, wherein 3D models of the jigs arepositioned on 3D models of the target bones, such positioning beingemployed to determine cavity generation for the jigs that will allow theactual resulting jigs to matingly receive the actual correspondingsurfaces of the actual target bones [blocks 706 and 708]. Theinformation determined from the surgical planning is used to CNC machineor otherwise manufacture (e.g., SLA or other rapid prototypingmanufacturing processes) the femoral and tibial jigs [block 710]. Oncethe femoral and tibial jigs are created, the jigs 2 a, 2 b are sent tothe surgeon for review [block 712]. The jigs are sterilized before use[block 714]. The surgeon prepares the site for the arthroplastyprocedure (i.e. makes an incision, etc.), The surgeon fits the femoraljig 2 a onto the femur such that the femoral jig 2 a matingly receivesthe corresponding surfaces of the target bone, the jig 2 a then beingsecured to and stabilized on the target bone via pins drilled throughthe jig 2 a and into the target bone [block 716]. The surgeon makesguided cuts in the femur via the guide surfaces in the femoral jig 2 a[block 718]. The surgeon then fits the tibial jig 2 b onto the tibiasuch that the tibial jig 2 b matingly receives the correspondingsurfaces of the target bone, the jig 2 b then being secured to andstabilized on the target bone via pins drilled through the jig 2 b andinto the target bone [block 720]. The surgeon makes guided cuts into thetibia via the guide surfaces in the tibia jig 2 b [block 722]. After thecuts are made, the jigs 2 a, 2 b may be discarded and the implantationof the femur and tibia implants can take place [block 724].

Depending on the type of arthroplasty jig desired, the systems andmethods disclosed herein may be applied to both the production ofnatural alignment arthroplasty jigs, zero degree mechanical axisalignment jigs, or arthroplasty jigs configured to provide a result thatis somewhere between natural alignment and zero degree mechanical axisalignment.

Although the present invention has been described with reference topreferred embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A tibial arthroplasty jig for assisting in theperformance of a tibial arthroplasty procedure on an arthroplasty targetregion of a tibia of a patient's knee joint, the tibia including amedial articular plateau surface, an intercondyloid eminence surfacehaving a medial upslope, a generally planar area of an anterior side ofa tibial shaft, a tibial plateau edge, a tibial tuberosity, and a regionextending from anterior the intercondyloid eminence to towards thetuberosity over an edge transition from a tibial plateau region, thetibial arthroplasty procedure being associated with an implantation of aprosthetic tibial implant, the jig comprising: a mating surfaceincluding a customized surface contour that is generally a negative ofthe medial articular plateau surface, the intercondyloid eminencesurface, and the generally planar area of the anterior side of thetibial shaft, wherein the mating surface is configured to make contactwith the tibia that includes, and is limited to, contact with the medialarticular plateau surface, the intercondyloid eminence surface, and thegenerally planar area of the anterior side of the tibial shaft when thejig is applied to the tibia to perform the tibial arthroplasty procedureon the arthroplasty target region.
 2. The tibial arthroplasty jig ofclaim 1, further comprising a cutting guide surface positioned andoriented relative to the mating surface to result in a cut in thearthroplasty target region with a desired position and orientation. 3.The tibial arthroplasty jig of claim 2, wherein the desired position andorientation allows the prosthetic tibial implant to restore thepatient's knee joint to a natural alignment.
 4. The femoral arthroplastyjig of claim 2, further comprising a jig body of unitary constructionand wherein the cutting guide surface and the mating surface are definedin the jig body.
 5. The tibial arthroplasty jig of claim 1, wherein thecontact with the generally planar area of the anterior side of thetibial shaft is limited to being generally distal of the tibial plateauedge and generally proximal of the tibial tuberosity.
 6. The tibialarthroplasty jig of claim 1, wherein the contact with the intercondyloideminence is limited to the medial upslope of the intercondyloideminence.
 7. The tibial arthroplasty jig of claim 1, wherein the contactwith the intercondyloid eminence is generally limited to the medialupslope of the intercondyloid eminence and the region extending fromanterior the intercondyloid eminence to towards the tuberosity over theedge transition from the tibial plateau region.
 8. The tibialarthroplasty jig of claim 7, wherein the contact with the intercondyloideminence merges with contact associated with the generally planar areaof the anterior side of the tibial shaft.
 9. The tibial arthroplasty jigof claim 1, wherein the jig is a unicompartmental tibial arthroplastyjig configured for assisting in the performance of a unicompartmentaltibial arthroplasty procedure.
 10. A tibial arthroplasty jig forassisting in the performance of a tibial arthroplasty procedure on anarthroplasty target region of a tibia of a patient's knee joint, thetibia including a generally planar area of an anterior side of a tibialshaft distal of a tibial plateau edge and generally proximal of a tibialtuberosity, the tibia further including a medial tibia condyle, thetibial tuberosity including a medial edge, a lateral edge, a proximalboundary and a beginning of a distal half to distal third of the tibialtuberosity the tibial arthroplasty procedure being associated with animplantation of a prosthetic tibial implant, the jig comprising: amating surface including a customized surface contour that is generallya negative of the generally planar area of the anterior side of thetibial shaft distal of the tibial plateau edge and generally proximal ofthe tibial tuberosity, wherein the mating surface is configured to maketibia contact that includes contact with the generally planar area ofthe anterior side of the tibial shaft distal of the tibial plateau edgeand generally proximal of the tibial tuberosity when the jig is appliedto the tibia to perform the tibial arthroplasty procedure on thearthroplasty target region.
 11. The tibial arthroplasty jig of claim 10,wherein the contact with the generally planar area extends distally fromgenerally the tibial plateau edge to generally even with the beginningof the distal half to distal third of the tibial tuberosity.
 12. Thetibial arthroplasty jig of claim 11, wherein the contact with thegenerally planar area extends medial-lateral from the medial edge of themedial tibia condyle to generally even with the medial edge of thetibial tuberosity.
 13. The tibial arthroplasty jig of claim 10, whereinthe contact with the generally planar area extends distally fromgenerally the tibial plateau edge to near the proximal boundary of thetibial tuberosity.
 14. The tibial arthroplasty jig of claim 13, whereinthe contact with the generally planar area extends medial-lateralgenerally between the lateral edge and the medial edge of the tibialtuberosity.
 15. The tibial arthroplasty jig of claim 10, furthercomprising a cutting guide surface positioned and oriented relative tothe mating surface to result in a cut in the arthroplasty target regionwith a desired position and orientation.
 16. The tibial arthroplasty jigof claim 15, wherein the desired position and orientation allows theprosthetic tibial implant to restore the patient's knee joint to anatural alignment.
 17. The tibial arthroplasty jig of claim 15, furthercomprising a jig body of unitary construction and wherein the cuttingguide surface and the mating surface are defined in the jig body. 18.The tibial arthroplasty jig of claim 10, wherein the jig is aunicompartmental tibial arthroplasty jig configured for assisting in theperformance of a unicompartmental tibial arthroplasty procedure.